Compliance Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Develop and oversee UpDoc's compliance infrastructure related to medical device quality and regulatory standards, health data privacy and security, healthcare fraud and abuse, clinical governance and licensure, as well as federal research compliance.

• Collaborate with the Regulatory and Quality team to address compliance requirements that intersect with UpDoc's FDA-regulated products and quality systems.

• Ensure that broader compliance policies and processes are in alignment with regulatory and quality standards.

• Provide support for cross-functional compliance considerations as products, clinical programs, partnerships, and reimbursement models evolve.

• Act as HIPAA Privacy Officer and work in coordination with the Security Officer on the HIPAA Security program.

• Manage Business Associate Agreements, minimum-necessary practices, breach assessment and notification procedures, and documentation of data flow.

• Collaborate with Security on SOC 2 Type II and HITRUST readiness and lead responses to health system vendor risk assessments.

• Offer guidance on federal and state privacy regulations, including HIPAA, CCPA/CPRA, and emerging health data privacy laws.

• Develop compliance frameworks for care management, remote monitoring, and other reimbursement pathways.

• Evaluate arrangements under the Anti-Kickback Statute, Stark Law, and beneficiary inducement rules with external legal counsel.

• Maintain compliance with the Corporate Practice of Medicine across operating states.

• Establish and supervise clinician credentialing, licensure, scope of practice, and supervision requirements.

• Ensure that care is documented, escalated, and audited in accordance with clinical governance standards and partner health system requirements.

• Support federally funded research and grant compliance, including human subjects protections, IRB coordination, data management, and cost allowability.

• Uphold conflict of interest and research integrity policies.

• Draft, maintain, and provide training on company policies and procedures.

• Lead the annual compliance risk assessment and develop the work plan.

• Establish compliance training, reporting mechanisms, and the schedule for audits and monitoring.

• Prepare regular compliance and risk reports for the CEO and Board.

• Act as the primary compliance liaison for customer legal, privacy, and IT security teams during contracting and implementation phases.

• Coordinate efforts with outside counsel, auditors, and specialized advisors.

⛳️ Requirements

• A minimum of 8 years of healthcare compliance experience, with at least 3 years in a leadership or program-owner position.

• Experience in working with FDA-regulated software or digital health products, possessing a strong understanding of SaMD quality systems and post-market obligations.

• Extensive knowledge of HIPAA Privacy and Security Rules, along with experience in negotiating Business Associate Agreements with health systems.

• Experience in supporting SOC 2, HITRUST, or similar healthcare security and compliance frameworks.

• Familiarity with Medicare care management reimbursement compliance and healthcare fraud and abuse laws.

• Proven track record of building compliance programs from inception rather than solely managing existing ones.

• Ability to convert regulatory guidance into practical advice for engineers, clinicians, and executives, while maintaining firm compliance standards when necessary.

• Experience at a digital health or clinical AI company that engages with large health systems or academic medical centers.

• Exposure to federal research compliance, including NIH, ARPA-H, or similar federally funded initiatives.

• Knowledge of AI-specific regulatory developments, including FDA guidance on AI-enabled device software and predetermined change control plans.

• Relevant certifications such as CHC, CHPC, CIPP/US, or RAC are preferred.

• A JD, MPH, MHA, or equivalent graduate degree is strongly preferred; a clinical background is advantageous.

• Must possess current authorization to work in the United States without employer sponsorship.

🏝️ Benefits

• Comprehensive health benefits package.

• Opportunities for professional development and continuous learning.

• Flexible work arrangements.

• Collaborative and innovative work environment.